Author: jay67o52540

 The Medical Imaging & Technology Alliance (MITA), the leading trade association representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media and focused ultrasound therapeutic devices, called for the U.S. Food and Drug Administration’s (FDA) to strengthen its guidance on medical device remanufacturing and urged the Agency to take the necessary steps to properly enforce the regulatory requirements associated with remanufacturing activities, including implementation of a quality management system, Federal registration and reporting of adverse events. “Central to the FDA protecting patient safety as pertains to remanufacturing, the Agency needs to know who these companies are and hold them accountable ... Read more